There are a number of factors driving rapid growth of the global biologics market today. For one, pharmaceutical and biotech companies are shifting more investment into the discovery and development of large molecule therapeutic proteins (as opposed to small, chemically manufactured active-substance molecules) because of their specificity, which enables targeting of previously hard-to-address conditions in disease states like oncology, neurology, and metabolic and infectious diseases. Because biologics bind to specific cell receptors that are associated with the disease process, they are less likely to affect healthy cells and therefore offer better efficacy with reduced risk of side effects. Additionally, with the help of technological advancements, we have been able to make significant improvements in our understanding of cell physiology and how to target various diseases at the cellular level; for example, next-generation cell and gene therapies are among some of the most promising novel treatments to address rare diseases. These factors, paired with recent, influential patent expiries, are fueling demand for innovative large molecule therapies across our industry.

The challenge is that biologic development and manufacturing processes are more complex than those for small molecule drugs, and expert bioanalytical testing experience is required to ensure biotherapeutics can uphold both clinical efficacy and safety. Small molecule drugs have simple, well-defined structures and can be produced through a predictable chemical process. Large molecule drugs, on the other hand, are comprised of many heterogeneous molecules and are produced in living cell culture, which makes them much more difficult to control; even the slightest manufacturing changes can have significant impact on the drug’s efficacy and/or immunogenicity.

Rather than bringing the advanced capabilities required to support these complexities in-house, many pharma and biotech companies are seeking to outsource testing to contract research organizations (CROs) that already possess the level of expertise and technology needed for successful biological drug development. In fact, the global biologics outsourcing market is expected to reach $32B by 2024 – up from $8.42B in 2016.

Quantity Cannot Compromise Quality
It is anticipated that biologics will comprise 50% of the top 100 drugs by 2021, compared to current figures of approximately 20% today. More pharma and biotech companies will be looking to move more innovative biotherapeutics through the development pipeline as efficiently as possible, and outsourcing gives sponsors ready access to increased capacity and specialized expertise as they contend with growing demand and competition in the large molecule space. But, given the inherent structural complexities of biological drugs, combined with the highly regulated nature of large molecule manufacturing processes, adherence to stringent quality standards will be a necessary part of bringing these innovations to market.

To maintain quality oversight as more biologics enter their pipeline, sponsor companies are beginning to shift away from using multiple outsourced partners and instead have focused on identifying a few key strategic partners. This not only decreases overall project management complexity, but helps to mitigate quality pitfalls that can occur during project handoffs between vendors. Most of all, aligning with a CRO that has the expertise to effectively navigate scientific and regulatory challenges at every phase of large molecule drug development can accelerate processes and ultimately decrease time to market for these much needed therapies.

Unfortunately the reality is that there are more large molecule drugs in development than there are quality CROs available to support them. Advancements in this field are happening at a fast and furious pace, and it takes an organization that is dedicated to continuously investing in their people and technology, ensuring the scientific capabilities and resources are in place to address new bioanalytical testing challenges that sponsors bring – efficiently and with robust, reliable results.

Selecting a Quality CRO for the Future, Today
As companies seek to advance innovative biologics – from those that leverage gene therapy to ADCs to immune oncological approaches – bioanalytical testing will only grow more intricate. For that reason, and to be a true strategic outsourced partner for a sponsor, a ‘quality CRO’ must possess both a breadth and depth of large molecule expertise, hands-on skill, and importantly, creativity. They should have diverse experience in the techniques specific to large molecule bioanalysis, and be able to apply knowledge from related projects to support the sponsor’s own novel biological product development needs. This will help the sponsor to optimize outcomes because the CRO will have the perspective needed to proactively identify and address areas of scientific or regulatory concern before they create costly delays.

This level of expertise requires focus, making specialization in large molecule bioanalysis a key differentiator for sponsors to look for when selecting a strategic CRO partner. Rather than splitting their time between small and large molecule, specialized large molecule bioanalytical labs can commit all of their efforts to understanding and integrating into their processes the most innovative approaches for biologics testing. They are also more likely to invest in technologies and platforms that specifically support large molecule drug development, giving sponsors access to state-of-the-art tools and capacity without the long lead times of implementing such resources in-house. A CRO team that is well-versed in the regulatory realities unique to the production of biological drugs, including the fact that these therapies can elicit unwanted immune responses, will be able to provide reliable, quality data on the safety and efficacy of a drug candidate, giving sponsors the insight to make confident, faster ‘go’ or ‘no-go’ decisions on which therapies to invest further time and efforts.

Quality Science without Compromise: The BioAgilytix Way
In order to progress therapies with the most hope of making meaningful change in patients’ lives, unwavering bioanalytical testing quality will be of the utmost importance. No one wants to see a potentially life-saving biotherapeutic shelved because bioanalysis was too complex or done in error.

BioAgilytix is able to uphold this level of scientific quality because we are solely focused on large molecule bioanalysis. We invest in the best and brightest scientific talent in the large molecule area of study, and equip them with the innovative technology and tools they need to deliver robust, reliable bioanalytical testing results. Our scientific team averages 15+ years of bench experience, and its members bring with them diverse in-lab experience supporting large molecule projects through all phases of development. They are led by industry thought leaders that are globally recognized as subject matter experts in biomarkers, biosimilars, immunoassays, and other innovative bioanalytical methods. In fact, many of our scientists are actively contributing to guidance that is helping to shape bioanalytical methods and requirements for large molecule drug development. We believe that this level of expertise is demanded for our sponsors to keep pace with the promise that biologic drugs hold to more effectively treat or cure chronic and rare diseases.

While quality science is critical, it must also be delivered in a way that brings the most value to pharma and biotech sponsors, so that innovative therapies remain economically viable throughout development and can get to market as quickly as possible. BioAgilytix understands these demands and we have implemented a number of methodologies to ensure our service quality equals the high level of our scientific quality. Our expert team works as a true extension of internal sponsor teams, collaborating with transparency throughout each project to address potential challenges early, problem-solve with creative solutions, and increase efficiencies throughout the process.

A Bright Future with Quality at the Core
There is no doubt that the biologics market will continue to grow and evolve, and with that growth comes many new opportunities for pharma and biotech companies and the patients they serve. If our industry continues to make quality a core focus in every aspect of the large molecule drug development process, then we will be able to rise to the demands of innovation and deliver more effective, safer therapies for the individuals that need them most.